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- SCCS Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6)– SCCS/1669/24Publication . Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Ezendam, Janine; Gaffet, Eric; Galli, Corrado L.; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; Stepnik, Maciej; Vanhaecke, Tamara; Wijnhoven, Susan; Benfenati, Emilio; Corsini, Emanuela; Koutsodimou, Aglaia; Aglaia Koutsodimou; Louro, Henriqueta; Uter, Wolfgang; von Goetz, NatalieHighlights: -o-Phenylphenol (OPP) is safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off cosmetic products; - o-Phenylphenol (OPP) is safe when used as preservative up to a maximum concentration of 0.15 % in leave-on cosmetic products; - Sodium o-Phenylphenate is safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off cosmetic products; - Sodium o-Phenylphenate is safe when used as preservative up to a maximum concentration of 0.15 % in leave-on cosmetic products; - OPP and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.15 % in leave-on cosmetic products; - OPP and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.2 % in rinse-off cosmetic products; - Since this safety dossier related to dermally applied products only, the SCCS did not consider oral and inhalation routes; - This assessment did not cover the safety of O-Phenylphenol and Sodium o-Phenylphenate for the environment.
- Re‐evaluation of neotame (E 961) as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Bruzell, Ellen; Chipman, James; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Gaffet, Eric; Karlien, Cheyns; Halldorsson, Thorhallur; Leblanc, Jean‐Charles; Lindtner, Oliver; Loeschner, Katrin; Mast, Jan; Mirat, Manuela; Mortensen, Alicja; Undas, Anna; Wright, Matthew; Barmaz, Stefania; Civitella, Consuelo; Abrahantes, Jose Cortiñas; Le Gall, Pauline; Mazzoli, Elena; Mech, Agnieszka; Rasinger, Josef Daniel; Rincon, Ana; Riolo, Francesca; Smeraldi, Camilla; Tard, Alexandra; Zakidou, Panagiota; Lodi, FedericaThe present opinion deals with the re‐evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine 1‐methyl ester. The main impurity of neotame (E 961) is also a degradation product (de‐esterified form), N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine (NC‐00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre‐systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of neotame (E 961) at the maximum permitted levels or reported use levels. A review of the other endpoints from the already available toxicological database did not indicate an adverse effect for neotame at the highest doses tested. The Panel established an acceptable daily intake (ADI) of 10 mg/kg bw per day for neotame based on the no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day from a 52‐week chronic and 104‐week carcinogenicity studies in rats. This ADI replaces the ADI of 2 mg/kg bw per day established by EFSA in 2007. The resulting exposure to methanol and its metabolite formaldehyde from the use of neotame at the ADI of 10 mg/kg bw per day does not raise a concern. The dietary exposure estimates of neotame (E 961) for the different population groups of all exposure scenarios did not exceed the ADI. The Panel concluded that there is no safety concern for neotame (E 961) at the currently permitted and reported uses and use levels. The Panel recommended the European Commission to consider revising the EU specifications of neotame (E 961).
- Impact of wildfire emissions exposure on the associations between levels of lung injury, lipid peroxidation, DNA oxidation, and exposure biomarkersPublication . Barros, Bela; Paiva, Ana Margarida; Azevedo, Rui; Alves, Sara; Esteves, Filipa; Fernandes, Adília; Vaz, Josiana; Alves, Maria José; Slezakova, Klara; Teixeira, João Paulo; Costa, Solange; Almeida, Agostinho; Oliveira, Marta; Morais, SimoneFirefighters face increased risks of developing cardio-respiratory diseases and cancer. This study aimed, for the first time, to simultaneously characterize several biomarkers of effect (lung injury by Clara cell 16 -CC16, lipid peroxidation by 8-isoprostane-8-iso, and DNA oxidation by 8-hydroxy-2-deoxyguanosine-8-OHdG) and exposure (polycyclic aromatic hydrocarbons metabolites - 6 OHPAHs and 17 metal(loid)s) in (pre- and post-exposure) paired urine samples of wildland firefighters, while exploring their inter-/intra-associations and accounting for tobacco consumption. Wildfire combat influenced the levels of CC16 (+39 %), 8-iso (+33 %), 8-OHdG (-13 to +19 %), individual and sum of OHPAHs (+75-211 %), and metal(loid)s (up to 43 %, p > 0.05: lithium, zinc, antimony, and lead); post-exposure increments were more evident among non-smokers. Post-exposure (individual and sum) OHPAHs and some metal(loid)s (copper, cadmium, barium, antimony, copper, lead, zinc, selenium, and rubidium) were positively associated with CC16, 8-iso and/or 8-OHdG (0.609 < r < 0.838; 0.001 < p < 0.047). Spearman's correlations and principal component analysis highlighted CC16 as the best discriminant effect biomarker of wildland firefighting, correlating positively with individual and sum of OHPAHs, cadmium, barium and copper (0.647 < r < 0.764; 0.006 < p < 0.031). Cumulative exposure to wildfires and tobacco contributed to positive correlations (0.587 < r < 0.715; 0.009 < p < 0.045) between lipid peroxidation and arsenic, antimony, lead, and copper, and between DNA oxidation and lead. Smoking firefighters presented higher OHPAHs baseline concentrations (2- to 14-fold), and lung injury and DNA oxidation induced by cadmium, copper, strontium, cesium, barium and thallium (0.661 < r < 0.709; 0.022 < p < 0.038). Given firefighter's carcinogenic risks, performing similar studies in larger groups is crucial to enhance risk assessment by establishing a well-defined panel of effect and exposure biomarkers.